Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT05112133
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2021-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723317', 'term': 'Morus alba'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-05', 'studyFirstSubmitDate': '2021-09-30', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-prandial glucose', 'timeFrame': 'Hour 0 to hour 3 after standard meal consumption', 'description': 'Incremental area under the curve'}], 'secondaryOutcomes': [{'measure': 'C max glucose', 'timeFrame': 'Hour 0 to hour 3 after standard meal consumption', 'description': 'Incremental C max'}, {'measure': 'T max glucose', 'timeFrame': 'Hour 0 to hour 3 after standard meal consumption', 'description': 'Incremental T max'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-prandial Glycemia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test the effects of Mulberry leaf extract on glucose response of a standardized complete meal when taken just before or when mixed with the meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants\n* Healthy status (based on anamnesis)\n* Age between 18 and 45 years\n* BMI between 20 and 29.9 kg/m2\n* Ability to understand and sign an informed consent form\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments\n* Known food allergy and intolerance to test product\n* Medically known cutaneous hypersensitivity to adhesives and plasters\n* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.\n\nSmokers\n\nVolunteer who cannot be expected to comply with the protocol\n\nSubject having a hierarchical link with the research team members.'}, 'identificationModule': {'nctId': 'NCT05112133', 'briefTitle': 'Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal', 'orgStudyIdInfo': {'id': '19.09 NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Water administrated just before a meal', 'interventionNames': ['Dietary Supplement: Water']}, {'type': 'EXPERIMENTAL', 'label': 'Mulberry leaf extract before', 'description': '250 mg of Mulberry leaf extract was administered before a standard meal', 'interventionNames': ['Dietary Supplement: Mulberry leaf extract']}, {'type': 'EXPERIMENTAL', 'label': 'Mulberry leaf extract during', 'description': '250 mg of Mulberry leaf extract was administered during a standard meal', 'interventionNames': ['Dietary Supplement: Mulberry leaf extract']}], 'interventions': [{'name': 'Mulberry leaf extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration', 'armGroupLabels': ['Mulberry leaf extract before', 'Mulberry leaf extract during']}, {'name': 'Water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Nestlé Clinical Research Unit', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}